BOOST - Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement

Heart Failure Clinical Trial

Official title: BOOST: Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement

Status Terminated

Clinical Trial Summary

Cardiac resynchronization therapy (CRT) has shown improvement in mortality and morbidity in patients with left ventricular systolic dysfunction and congestive heart failure. Additionally in CRT patients it has been demonstrated that optimizing paced/sensed atrioventricular (AV) and interventricular (V-V) timings leads to immediate hemodynamic benefits and further improves cardiac function. Recent studies have shown that optimal paced/sensed AV and V-V delays change over time, which raises the question of how often optimization should be repeated. Thus, frequent re-optimization of these delays might be beneficial for maintaining significant improvement of cardiac function. However, it remains to be evaluated whether timing optimization may be beneficial on patients who have received CRT for a number of years and are now having the CRT device replaced.

Clinical Trial Description

• This is a prospective, randomized, and multicenter study

• Patients who have received a replacement St. Jude Medical(SJM) CRT device, either CRT-P or CRT-D, within the last two weeks post CRT replacement will be considered for enrollment in the study.

• Baseline measurements will be performed at the time of enrollment.

• Patients are followed up to 12 months post CRT replacement with data collected at 3, 6, 9 and 12 months post CRT replacement.

• Patients will be randomized at enrollment to either Group 1 (use of SJM algorithm to optimize programming) or Group 2 ("Control"). ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT00929474
• Study type: Interventional
• Source: Abbott Medical Devices
• Status: Terminated
• Phase: N/A
• Start date: June 2009
• Completion date: September 2010